# US 11,027,123 B2 · Systems and methods to place one or more leads in tissue to electrically stimulate nerves of passage to treat pain

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- Number: US 11,027,123 B2
- Document ID: US11027123B2
- Status: Granted
- Kind: B2
- Application number: 16/251,482
- Filed: 2019-01-18
- Published: 2019-05-23
- Granted: 2021-06-08
- Earliest claimed: 2008-12-05
- Assignees: Spr Therapeutics, Inc.
- Applicants: Spr Therapeutics, Inc.
- Inventors: Joseph W. Boggs; Rosemary H. Zang
- Web page: https://patentgrep.com/patent/US11027123B2

## CPC

- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0502: {Skin piercing electrodes}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/36021: {for treatment of pain}
- A61N 1/36071: {Pain}
- A61B 5/061: {Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body (A61B1/00158 takes precedence)}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems and methods are provided for applying electrical stimulation to a body by an electrode spaced from a target nerve of passage. It has been discovered that pain felt, or perceived to be felt, in a given region of the body can be treated by stimulating muscle close to a “nerve of passage” in a region that is superior (i.e., cranial or upstream toward the spinal column) to the region where pain is felt, such as in a case of post-amputation residual limb pain, or purportedly felt in the case of post-amputation phantom limb pain.

## Claims

### Claim 1

A system comprising:
an electrode positioned in tissue a distance spaced from (i) at least one of a Type Ia and Ib afferent nerve fibers and (ii) at least one of Type III and Type IV nerve fibers; and
an electrical stimulation device operatively coupled with the electrode, wherein the electrical stimulation device delivers electrical stimulation through the electrode to selectively activate at least one of the Type Ia and Ib afferent nerve fibers while minimizing recruitment of activation of the at least one of the Type III and Type IV nerve fibers because the electrode is spaced the distance from the at least one of a Type Ia and Ib afferent nerve fibers and the at least one of Type III and Type IV nerve fibers to reduce a perception of pain.

### Claim 2 (depends on 1)

The system of claim 1 further comprising a lead comprising at least one conductive wire, the lead positioned between the electrode and the electrical stimulation device.

### Claim 3 (depends on 1)

The system of claim 1, wherein the electrode is positioned on a distal end of a coiled fine wire lead.

### Claim 4 (depends on 1)

The system of claim 1, wherein the lead is a percutaneous lead.

### Claim 5 (depends on 1)

The system of claim 1, wherein the lead is coiled fine wire lead.

### Claim 6 (depends on 1)

The system of claim 1, wherein the electrical stimulation device comprises an implantable pulse generator.

### Claim 7 (depends on 1)

The system of claim 1, wherein the electrical stimulation device comprises an external pulse generator.

### Claim 8

A system comprising:
an electrode positioned in tissue in electrical proximity to but spaced away from a neural fiber bundle within a body, wherein the neural fiber bundle comprises at least one of a Type Ia and Ib afferent nerve fiber and an efferent nerve fiber; and
an electrical stimulation device delivering electrical stimulation from the electrode to the neural fiber bundle to reduce a perception of pain, wherein the at least one of Type Ia and Ib afferent nerve fiber of the neural fiber bundle are selectively activated while minimizing recruitment of activation of the efferent nerve fiber of the neural fiber bundle because the electrode is in electrical proximity but spaced away from the neural fiber bundle to reduce a perception of pain.

### Claim 9 (depends on 8)

The system of claim 8, wherein selectively activating at least one of the Type Ia and Ib afferent nerve fibers includes selectively activating both of the Type Ia and Ib afferent nerve fibers.

### Claim 10 (depends on 8)

he system of claim 8, wherein minimizing recruitment of activation includes minimizing recruitment of activation of at least one of a Type III and Type IV nerve fiber of the neural fiber bundle.

### Claim 11 (depends on 8)

The system of claim 8, wherein minimizing recruitment of activation includes minimizing recruitment of activation of both the Type III and Type IV nerve fibers of the neural fiber bundle.

### Claim 12 (depends on 8)

The system of claim 8, wherein the electrode is a monopolar electrode.

### Claim 13 (depends on 8)

The system of claim 8, wherein the electrical proximity to but spaced away from a neural fiber bundle comprises 0.5 to 3 cm from the neural fiber bundle.

### Claim 14 (depends on 8)

The system of claim 8 wherein the electrode is a percutaneous electrode.

### Claim 15 (depends on 8)

The system of claim 8, wherein the electrode is positioned on a distal end of a coiled fine wire lead.

### Claim 16 (depends on 8)

The system of claim 8, wherein the lead is a percutaneous lead.

### Claim 17 (depends on 8)

The system of claim 8, wherein the lead is coiled fine wire lead.

### Claim 18 (depends on 8)

The system of claim 8, wherein the electrical stimulation device comprises an implantable pulse generator.

### Claim 19 (depends on 8)

The system of claim 8, wherein the electrical stimulation device comprises an external pulse generator.

### Claim 20

A system comprising:
an electrode positioned at a therapeutically effective distance from a neural fiber bundle within tissue, wherein the neural fiber bundle comprises more than one type of nerve fiber;
an electrical stimulation device operatively coupled with the electrode, the electrical stimulation delivers electrical stimulation from the electrode to the neural fiber bundle to reduce a perception of pain by said human, wherein a first of the type of nerve fiber is selectively activated while minimizing recruitment of activation of a second of the type of nerve fiber because the electrode is at the therapeutically effective distance and wherein the electrical stimulation evokes paresthesia in a region of pain, wherein the region of pain is spaced from the electrode.

### Claim 21 (depends on 20)

The system of claim 20, wherein the therapeutically effective distance is 0.2 centimeters to 3.0 centimeters from the neural fiber bundle.

### Claim 22 (depends on 20)

The system of claim 20, wherein the first type of the type of nerve fiber comprises at least one of Type Ia and Ib afferent nerve fibers and the second of the type of nerve fiber comprises at least one of a Type III, Type IV and efferent nerve fibers.

### Claim 23 (depends on 20)

The system of claim 20 further comprising an introducer needle, wherein the electrode is placed using the introducer needle percutaneously inserted into the tissue.

### Claim 24 (depends on 20)

The system of claim 20 wherein the electrode is a percutaneous electrode.

### Claim 25 (depends on 20)

The system of claim 20, wherein the electrode is positioned on a distal end of a coiled fine wire lead.

### Claim 26 (depends on 20)

The system of claim 20, wherein the lead is a percutaneous lead.

### Claim 27 (depends on 20)

The system of claim 20, wherein the lead is coiled fine wire lead.

### Claim 28 (depends on 20)

The system of claim 20, wherein the electrical stimulation device comprises an implantable pulse generator.

### Claim 29 (depends on 20)

The system of claim 20, wherein the electrical stimulation device comprises an external pulse generator.
